Senior Regulatory Affairs Program Lead – MedTech Robotics

About the role

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to drive regulatory strategy and execution for the OTTAVA robotics portfolio within its MedTech Surgery division. The role supports both US and international market approvals and works closely with engineering and clinical teams to bring innovative surgical solutions to market.

Key responsibilities

• Develop and execute regulatory strategies for new product development (NPD) and lifecycle management (LCM) projects.
• Lead preparation, writing, and filing of FDA submissions such as Q‑submissions, IDEs, De Novo, and 510(k) applications, and coordinate FDA meeting preparation.
• Provide expert regulatory feedback on specifications, device testing, risk management, labeling, and related documentation for electromechanical devices with software functionality.
• Manage sustaining activities including change assessments, registrations, renewals, and support global health authority submissions.
• Support audits and maintain compliance with relevant guidances, regulations, and standards.

Required profile

• Minimum Bachelor’s degree (Advanced degree preferred) with at least 6 + years of medical device regulatory affairs experience, including software‑enabled systems.
• Proven track record of obtaining US regulatory approvals (e.g., 510(k), IDE, De Novo).
• Strong collaborative and communication skills, able to influence cross‑functional teams.
• Strategic thinker capable of synthesizing regulatory guidance and trends into actionable strategies.
• Willingness to travel up to 10 % and work remotely or on‑site as needed.

Required skills

• FDA software and cybersecurity regulatory requirements
• IEC 60601 series standards
• ISO 10993‑1 standard
• Vision systems and robotics expertise
• Connected medical platform knowledge

What we offer

• Base salary range $125,000 – $201,250 per year
• Comprehensive benefits including retirement plans, paid time off, parental leave, and volunteer leave
• Inclusive work environment aligned with Johnson & Johnson’s Credo